JP2018175313A - Medical appliance - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical appliance capable of locally administering a cell in a transvascular manner toward target tissue.SOLUTION: A medical appliance for being indwelled in a blood vessel includes a hollow needle part that is pierced through a peripheral wall of the blood vessel within the blood vessel so as to communicate the inside and outside of the blood vessel with each other, and an embolization part that is arranged on the downstream side in the extension direction of the blood vessel with respect to the hollow needle part within the blood vessel and brought into contact with a body fluid within the blood vessel so as to embolize the blood vessel.SELECTED DRAWING: Figure 3

Description

  The present disclosure relates to medical devices.

  BACKGROUND ART Conventionally, cancer immunotherapies for improving immunity and treating cancer are known. Among cancer immunotherapies, there are immune cell therapies that enhance the function of patient's immune cells to treat cancer. In this immune cell therapy, the patient's immune cells are taken out of the body, cultured and activated, and returned to the patient's body, thereby enhancing immunity to cancer cells and treating cancer. Patent Document 1 describes an example of cancer immunotherapy.

JP-A-2017-503472

  By the way, a medical device or a cell administration method for locally administering a predetermined cell such as an immune cell to a target tissue transvascularly has not been established.

  The present disclosure aims to provide a medical device capable of locally administering cells transvascularly to a target tissue.

  A medical device according to a first aspect of the present invention is a medical device to be indwelled in a blood vessel, comprising a hollow needle portion for piercing the peripheral wall of the blood vessel in the blood vessel and communicating the inside and the outside of the blood vessel; And an embolic unit disposed in the vessel downstream of the hollow needle in the extending direction of the vessel and touching the body fluid in the vessel to embolize the vessel.

  The medical device as one embodiment of the present invention includes a biasing unit which moves or deforms the hollow needle portion from the non-piercing state of the peripheral wall to the piercing state in the vessel.

  As one embodiment of the present invention, the biasing portion includes an expandable portion which can expand radially outward of the vessel in the vessel, and the hollow needle portion follows the expansion of the dilation portion. Move to pierce the peripheral wall.

  As one embodiment of the present invention, a plurality of the hollow needle portions are provided in the circumferential direction of the vessel while being indwelled in the vessel.

  As one embodiment of the present invention, a plurality of the hollow needle portions are provided in the extension direction of the vessel while being indwelled in the vessel.

  In one embodiment of the present invention, the embolic portion includes a thrombogenic substance that acts in contact with body fluid in the vessel to swell or coagulates body fluid in the vessel.

  As one embodiment of the present invention, the embolic unit includes an expandable body that retains the thrombus producing substance and radially expands the vessel in the vessel.

  In one embodiment of the present invention, the expandable body is a reticulated member.

  According to the present disclosure, a medical device capable of locally administering cells to a target tissue transvascularly can be provided.

It is a figure which shows the outline | summary of an example of a cancer immunotherapy. It is a figure which shows the single-piece | unit of the medical device as one Embodiment of this invention. It is a figure which shows the state by which the medical device shown in FIG. 2 was detained in the blood vessel. It is a figure which shows a mode that the medical device shown in FIG. 2 is conveyed to the predetermined position in a blood vessel.

  Hereinafter, an embodiment of a medical device according to the present invention will be described with reference to FIGS. 1 to 4. The same code | symbol is attached | subjected to the member and site | part which are common in each figure.

  FIG. 1 shows an outline of an example of cancer immunotherapy. In the cancer immunotherapy shown in FIG. 1, immune cells X are removed from the blood of patient P, activated and cultured, and returned to the blood of patient P again. As a result, the immunity of the patient P is enhanced, and elimination of cancer cells and suppression of the generation of cancer cells can be realized.

  FIGS. 2 and 3 are diagrams showing the medical device 1 according to this embodiment, which can be used for the cancer immunotherapy shown in FIG. In FIG. 2, the single-piece | unit of the medical device 1 is shown. FIG. 3 shows a state where the medical device 1 is indwelled in a blood vessel BV as a vessel. More specifically, FIG. 3 shows a state where the medical instrument 1 is indwelled in the vicinity of the upstream side of the blood vessel BV with respect to the target tissue T to be subjected to the cancer treatment. In addition, the medical device 1 of FIG. 2 is a side view, and the medical device 1 of FIG. 3 is a cross-sectional view.

  As shown in FIGS. 2 and 3, the medical device 1 includes a hollow needle portion 2, an embolic portion 3, and a biasing portion 4.

  As shown in FIG. 3, the hollow needle portion 2 pierces the blood vessel wall which is the peripheral wall of the blood vessel BV in the blood vessel BV as a blood vessel, and can communicate the inside and the outside of the blood vessel BV. In FIG. 3, the hollow needle 2 is shown penetrating the peripheral wall of the blood vessel BV. In this state, the inside and the outside of the blood vessel BV are in communication with the flow path 2 a of the hollow needle 2.

  Moreover, the hollow needle part 2 of this embodiment is provided in multiple numbers in the circumferential direction of the blood vessel BV in the state indwelled in the blood vessel BV. Furthermore, as shown in FIG. 3, the hollow needle portion 2 of the present embodiment is provided in the extending direction of the blood vessel BV in a state of being indwelled in the blood vessel BV. As described above, by disposing a plurality of hollow needle portions 2 penetrating the peripheral wall of the blood vessel BV in the state in which the medical device 1 is indwelled in the blood vessel BV, in the circumferential direction or extending direction of the blood vessel BV More cells such as immune cells X from the inside of the blood vessel BV through the outside of the blood vessel BV with respect to the target tissue T targeted for cancer treatment located downstream of the blood vessel B as compared with the configuration in which It can be administered.

  The material for forming the hollow needle portion 2 is preferably a material having biocompatibility, and can be a resin having biocompatibility, silicon, metal, ceramic and the like. Among these, the resin having biocompatibility is, for example, medical silicone, polylactic acid, polyglycolic acid, polycarbonate, and PEEK material, etc., and the metal having biocompatibility is stainless steel, titanium, and manganese. Etc. Also, biocompatible ceramics include alumina, zirconia, silicon carbide, and silicon nitride. In the case where the hollow needle portion 2 contains a drug and is dissolved by a solution given to the hollow needle portion 2 from the outside, the material for forming the hollow needle portion 2 may be a water-soluble polymer.

  Further, the length of the hollow needle portion 2 is preferably, for example, about several hundred μm to several mm. The width of the hollow needle portion 2 is preferably about several tens of μm to several hundreds of μm. In addition, the length of the hollow needle part 2 of this embodiment means the projection length L (refer FIG. 2) from the outer surface of the annular member as an expansion part of the urging | biasing part 4 mentioned later. Further, the width of the hollow needle portion 2 in the present embodiment means the maximum width D (see FIG. 2) of the hollow needle portion 2.

  As shown in FIG. 3, the embolic portion 3 is disposed downstream of the hollow needle portion 2 in the blood vessel BV in the extending direction of the blood vessel BV. Then, the embolic unit 3 contacts the blood as the body fluid in the blood vessel BV to form an embolus such as a thrombus, for example, and embolizes the blood vessel BV.

  Specifically, the embolus part 3 of the present embodiment includes a thrombus generating substance that swells in contact with blood as body fluid in a blood vessel BV as a vessel. As such a thrombus generating substance, for example, hydrogel can be mentioned. However, it may be a thrombogenic substance having an action of coagulating the blood in the blood vessel BV.

  More specifically, the embolic section 3 of the present embodiment holds a thrombus-generating substance, and includes a dilator capable of expanding radially outward of the blood vessel BV in the blood vessel BV. The expandable body of the present embodiment is a self-expanding reticulated member. 2 and 3 show the mesh member in the expanded state. This net-like member is a lump formed of wires, and a large number of internal spaces are formed between the wires. The mesh member can be contracted to reduce the internal space between the wires, and the mesh member in a contracted state can be accommodated in a delivery catheter 5 (see FIG. 4) described later. While being accommodated in the delivery catheter 5 (see FIG. 4) in a contracted state, the catheter is carried to a predetermined position in the blood vessel. In addition, the thrombus formation substance mentioned above is hold | maintained on the surface of the wire which comprises the reticulated member as an expansion body.

  As a wire constituting the reticulated member as the expanded body of the embolic section 3, various metal materials, polymer materials and the like are used. Examples include metallic materials such as stainless steel, tantalum, nickel-titanium alloys (including nitinol), biodegradable magnesium alloys and cobalt alloys (including cobalt-chromium-nickel alloys).

  Further, as the polymer material, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyvinyl chloride, polyamide elastomer, polyurethane, polyester, polyary Thermoplastic resins such as lane sulfide may be mentioned. Among them, biodegradable polymer materials which are degraded in vivo and in which the degradation products do not show toxicity are preferable. Examples of polymer materials that degrade in vivo include polylactic acid, poly (lactic acid-glycolic acid), polyglycolic acid, poly (lactic acid-ε-caprolactone), poly (glycolic acid-ε-caprolactone), poly-p -Dioxanone, poly (glycolic acid-trimethylene carbonate), poly-beta-hydroxybutyric acid etc. are mentioned.

  Although the reticulated member as the expandable body of the embolic section 3 of this embodiment is a self-expanding type in which the shape is memorized in a predetermined shape, a non-self-expanding type expanded by a balloon or the like, a self-expanding type and a non-self type It may be configured in combination with the extension type. As a surface treatment method of the wire which comprises a mesh-like member, chemical treatment by an oxidizing agent or fluorine gas etc., surface graft polymerization, plasma discharge treatment, corona discharge treatment, UV / ozone treatment, electron beam irradiation etc. are mentioned, for example.

  The biasing unit 4 moves or deforms the blood vessel BV from a state in which the hollow needle portion 2 does not pierce the peripheral wall of the blood vessel BV to a state in which the hollow needle portion 2 pierces the peripheral wall. More specifically, the biasing unit 4 includes an expansion portion which can expand radially outward of the blood vessel BV in the blood vessel BV, and the hollow needle portion 2 moves to follow the expansion of the expansion portion, Pierce the peripheral wall. In addition, the expansion part of the biasing part 4 of this embodiment supports the hollow needle part 2 on the outer surface, and is comprised by the annular member which can be expanded and contracted to the radial direction of blood vessel BV. Therefore, when the annular member as the expansion portion of the biasing portion 4 expands and deforms radially outward in the blood vessel BV, the hollow needle portion 2 moves outward in the radial direction of the blood vessel BV. As a result, the hollow needle portion 2 can be moved from a state in which the peripheral wall of the blood vessel BV is not pierced to a state in which the hollow needle portion 2 is pierced. The annular member as the expansion portion of the biasing portion 4 in the present embodiment is formed of a self-expanding stent, and is formed of the same material as the reticulated member as the expansion body of the embolic portion 3 described above. Can. As described above, the biasing unit 4 may be configured of only a self-expanding extension.

  Hereinafter, the method of indwelling the medical device 1 of this embodiment in the blood vessel BV shown in FIG. 3 will be described.

  FIG. 4 is a view showing how the medical instrument 1 is carried to a predetermined position in the blood vessel BV. As shown in FIG. 4, the medical device 1 is carried to a predetermined position of the blood vessel BV in a state of being housed in the delivery catheter 5. Then, the medical instrument 1 is discharged from the delivery catheter 5 into the blood vessel BV at a predetermined position of the blood vessel BV. Thereby, the self-expanding reticulated member of the embolic part 3 of the medical device 1 and the self-expanding stent of the biasing part 4 of the medical device 1 expand radially outward of the blood vessel BV. As a result, the medical instrument 1 can be brought into the state shown in FIG. When the medical device 1 is delivered and indwelled in a blood vessel, an inner delivery catheter which is extended and disposed in at least a part of the lumen of the medical device 1 can be used. In FIG. 4, the inner delivery catheter is not shown. After delivering the medical device 1 to the predetermined site, the inner delivery catheter is recovered. As an inner delivery catheter, a delivery catheter for a self-expandable stent or a balloon catheter for a balloon expandable stent can be used.

  Further, when the state of FIG. 4 is changed to the state of FIG. 3, the thrombus forming material held by the reticulated member as the expanded body of the embolic unit 3 contacts the blood in the blood vessel BV. Thereby, the thrombus-forming substance swells and fills a number of internal spaces formed between the wires constituting the reticulated member. Therefore, an embolism is formed by the reticulated member and the swollen thrombus forming substance, and the blood vessel BV is embolized at the position of the embolic portion 3 so that the blood flow can be stopped or weakened.

  Thereafter, as shown in FIG. 3, the medical device 1 is placed in the blood vessel BV in the vicinity of the target tissue T, and the blood vessel BV is carried out in a state of being embolized by the embolic unit 3. A method of locally administering cells for target tissue T in a vascular manner is described.

  As shown in FIG. 3, the blood flow of the blood vessel BV can be stopped or weakened by placing the medical device 1 in the indwelling state. Further, as shown in FIG. 3, the inside and the outside of the blood vessel BV are in communication with each other by the hollow needle portion 2. In this state, the tubular member 6 is inserted into the blood vessel BV, and the opening 6a formed at the tip of the tubular member 6 is advanced to the vicinity of the indwelling position of the medical device 1 (see FIG. 3). Then, predetermined cells such as immune cells X used for cancer treatment of the target tissue T are discharged from the opening 6 a through the tubular member 6. Thus, predetermined cells discharged near the indwelling position of the medical instrument 1 can move from inside the blood vessel BV to outside the blood vessel BV through the flow path 2 a of the hollow needle portion 2. That is, predetermined cells such as immune cells X can be administered outside the blood vessel BV and at a position near the target tissue T. Thus, by using the medical device 1 of the present embodiment, it is possible to locally administer predetermined cells such as immune cells X to the target tissue T transvascularly.

  In addition, after performing the cell administration mentioned above, in order to stop the outflow of the blood out of the blood vessel BV through the flow path 2a of the hollow needle part 2, for example, the treatment which embolises the upstream side of the blood vessel BV rather than the medical instrument 1 I do. However, the outflow of the blood from the blood vessel BV through the flow path 2a of the hollow needle part 2 may be stopped by another method.

  Further, predetermined cells to be locally administered in the above-described cell administration method are set according to the target tissue T and the purpose thereof. Therefore, predetermined cells to be administered locally are not limited to blood cells that are immune cells X (eg, lymphocytes (T cells, B cells, NK cells), red blood cells, granulocytes, monocytes, platelets), For example, hematopoietic stem cells, myoblasts, cardiomyocytes, fibroblasts, mesenchymal stem cells, synovial cells, embryonic stem cells, epithelial cells, endothelial cells, etc. may be used. In addition, the predetermined cells described above include allogeneic donor cells, xenogeneic donor cells, syngeneic donor cells, genetically engineered cells, established cell lines, cells derived from patients, and the like.

  The medical device according to the present disclosure is not limited to the items described in the above-described embodiment, and various changes and modifications can be made without departing from the scope of the claims.

  The present disclosure relates to medical devices.

1: Medical device 2: hollow needle 2a: flow channel 3: embolic unit 4: urging unit 5: delivery catheter 6: tubular member 6a: opening BV: blood vessel D: width of hollow needle L: hollow needle Length P: patient T: target tissue X: immune cells

Claims (8)

A medical device to be placed in a vessel,
A hollow needle that pierces a peripheral wall of the vessel in the vessel and communicates the inside and the outside of the vessel;
A medical instrument comprising: an embolic section disposed downstream of the hollow needle section in the vessel in the extending direction of the vessel and touching the body fluid in the vessel to embolize the vessel.   The medical instrument according to claim 1, further comprising: a biasing unit configured to move or deform the hollow needle unit from the non-piercing state to the piercing state in the vessel. The biasing portion comprises an expandable portion which is expandable radially outward of the vessel within the vessel;
The medical instrument according to claim 2, wherein the hollow needle moves to follow the expansion of the extension and pierces the peripheral wall.   The medical instrument according to any one of claims 1 to 3, wherein a plurality of the hollow needle portions are provided in the circumferential direction of the vessel in a state of being indwelled in the vessel.   The medical instrument according to any one of claims 1 to 4, wherein a plurality of the hollow needle portions are provided in the extension direction of the vessel while being indwelled in the vessel.   The medical treatment according to any one of claims 1 to 5, wherein the embolic part includes a thrombogenic substance having a function of swelling by touching with body fluid in the vessel or coagulating body fluid in the vessel. Appliance.   The medical device according to claim 6, wherein the embolic unit comprises an expandable body that holds the thrombus-generating substance and radially expands the vessel in the vessel.   The medical device according to claim 7, wherein the expandable body is a mesh member.

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